I 

115TH CONGRESS 

2D SESSION H. R. 5687 

To amend the Federal Food, Drug, and Cosmetic Act to require improved 

packaging and disposal methods with respect to certain drugs, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 7, 2018 

Mr. HUDSON (for himself, Mr. BUTTERFIELD, and Mr. BUDD) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

require improved packaging and disposal methods with 

respect to certain drugs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Securing Opioids and 

5 Unused Narcotics with Deliberate Disposal and Packaging 

6 Act of 2018’’ or the ‘‘SOUND Disposal and Packaging 

7 Act’’. 


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1 SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEAS2 URES WITH RESPECT TO THE PACKAGING OR 

3 DISPOSAL OF CERTAIN DRUGS. 

4 (a) IN GENERAL.—Chapter V of the Federal Food, 

5 Drug, and Cosmetic Act is amended by inserting after sec6 tion 505–1 (21 U.S.C. 355–1) the following new section: 

7 ‘‘SEC. 505–2. SAFETY-ENHANCING PACKAGING AND DIS8 POSAL FEATURES. 

9 ‘‘(a) ORDERS.— 

10 ‘‘(1) IN GENERAL.—The Secretary may, after 

11 consultation with relevant stakeholders, issue an 

12 order requiring the holder of a covered application to 

13 implement or modify one or more technologies, con14 trols, or measures with respect to the packaging or 

15 disposal of one or more drugs identified in the cov16 ered application, if the Secretary determines such 

17 technologies, controls, or measures to be appropriate 

18 to help mitigate the risk of abuse or misuse of such 

19 drug or drugs, including by reducing the availability 

20 of unused drugs. 

21 ‘‘(2) ASSURING ACCESS AND MINIMIZING BUR22 DEN.—Technologies, controls, or measures required 

23 under paragraph (1) shall— 

24 ‘‘(A) be commensurate with the specific 

25 risk of abuse or misuse of the drug listed in the 

26 covered application; 


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1 ‘‘(B) considering such risk, not be unduly 

2 burdensome on patient access to the drug, con3 sidering in particular the available evidence re4 garding the expected or demonstrated public 

5 health impact of such technologies, controls, or 

6 measures; and 

7 ‘‘(C) reduce the risk of abuse or misuse of 

8 such drug. 

9 ‘‘(3) ORDER CONTENTS.—An order issued 

10 under paragraph (1) may— 

11 ‘‘(A) provide for a range of options for im12 plementing or modifying the technologies, con13 trols, or measures required to be implemented 

14 by such order; and 

15 ‘‘(B) incorporate by reference standards 

16 regarding packaging or disposal set forth in an 

17 official compendium, established by a nationally 

18 or internationally recognized standard develop19 ment organization, or described on the public 

20 Internet website of the Food and Drug Admin21 istration, so long as the order includes the ra22 tionale for incorporation of such standard. 

23 ‘‘(4) ORDERS APPLICABLE TO DRUG CLASS.— 

24 When a concern about the risk of abuse or misuse 

25 of a drug relates to a pharmacological class, the SecVerDate Sep 11 2014 00:17 May 08, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5687.IH H5687

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1 retary may, after consultation with relevant stake2 holders, issue an order under paragraph (1) which 

3 applies to the pharmacological class. 

4 ‘‘(b) COMPLIANCE.—The holder of a covered applica5 tion shall— 

6 ‘‘(1) submit a supplement containing proposed 

7 changes to the covered application to comply with an 

8 order issued under subsection (a) not later than— 

9 ‘‘(A) 180 calendar days after the date on 

10 which the order is issued; or 

11 ‘‘(B)(i) such longer time period as speci12 fied by the Secretary in such order; or 

13 ‘‘(ii) if a request for an alternative date is 

14 submitted by the holder of such application not 

15 later than 60 calendar days after the date on 

16 which such order is issued— 

17 ‘‘(I) such requested alternative date if 

18 agreed to by the Secretary; or 

19 ‘‘(II) another date as specified by the 

20 Secretary; and 

21 ‘‘(2) implement the changes approved pursuant 

22 to such supplement not later than the later of— 

23 ‘‘(A) 90 calendar days after the date on 

24 which the supplement is approved; or 

25 ‘‘(B) the end of such longer period as is— 


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1 ‘‘(i) determined to be appropriate by 

2 the Secretary; or 

3 ‘‘(ii) approved by the Secretary pursu4 ant to a request by the holder of the cov5 ered application that explains why such 

6 longer period is needed, including to satisfy 

7 any other applicable Federal statutory or 

8 regulatory requirements. 

9 ‘‘(c) ALTERNATIVE MEASURES.—The holder of the 

10 covered application may propose, and the Secretary shall 

11 approve, technologies, controls, or measures regarding 

12 packaging, storage, or disposal other than those specified 

13 in the applicable order issued under subsection (a), if such 

14 technologies, controls, or measures are supported by data 

15 and information demonstrating that such alternative tech16 nologies, controls, or measures can be expected to mitigate 

17 the risk of abuse or misuse of the drug or drugs involved, 

18 including by reducing the availability of unused drugs, to 

19 at least the same extent as the technologies, controls, or 

20 measures specified in such order. 

21 ‘‘(d) DISPUTE RESOLUTION.—If a dispute arises in 

22 connection with a supplement submitted under subsection 

23 (b), the holder of the covered application may appeal a 

24 determination made with respect to such supplement using 


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1 applicable dispute resolution procedures specified by the 

2 Secretary in regulations or guidance. 

3 ‘‘(e) DEFINITIONS.—In this section— 

4 ‘‘(1) the term ‘covered application’ means an 

5 application submitted under subsection (b) or (j) of 

6 section 505 for approval under such section or an 

7 application approved under section 351 of Public 

8 Health Service Act, with respect to a drug that is 

9 or contains an opioid for which a listing in schedule 

10 II or III (on a temporary or permanent basis) is in 

11 effect under section 202 of the Controlled Sub12 stances Act; and 

13 ‘‘(2) the term ‘relevant stakeholders’ may in14 clude scientific experts within the drug manufac15 turing industry; brand and generic drug manufactur16 ers; standard development organizations; wholesalers 

17 and distributors; payers; health care providers; phar18 macists; manufacturers; poison centers; and rep19 resentatives of the National Institute on Drug 

20 Abuse, the National Institutes of Health, the Cen21 ters for Disease Control and Prevention, the Centers 

22 for Medicare & Medicaid Services, the Drug En23 forcement Agency, the Consumer Product Safety 

24 Commission, individuals who specialize in treating 

25 addiction, and patient and caregiver groups.’’. 


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1 (b) PROHIBITED ACTS.—Section 501 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend3 ed by inserting after paragraph (j) the following: 

4 ‘‘(k) If it is a drug approved under a covered applica5 tion (as defined in section 505–2(e)), the holder of which 

6 does not meet the requirements of paragraphs (1) and (2) 

7 of subsection (b) of such section.’’. 

8 (c) REQUIRED CONTENT OF AN ABBREVIATED NEW

9 DRUG APPLICATION.—Section 505(j)(2)(A) of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

11 355(j)(2)(A)) is amended— 

12 (1) in clause (vii)(IV), by striking ‘‘and’’ at the 

13 end; 

14 (2) in clause (viii), by striking the period at the 

15 end and inserting ‘‘; and’’; and 

16 (3) by adding at the end the following: 

17 ‘‘(ix) if the drug is or contains an 

18 opioid for which a listing in schedule II or 

19 III (on a temporary or permanent basis) is 

20 in effect under section 202 of the Con21 trolled Substances Act, information to 

22 show that the applicant has proposed tech23 nologies, controls, or measures related to 

24 the packaging or disposal of the drug that 

25 are comparably effective to those required 


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1 for the applicable listed drug under section 

2 505–2, if applicable.’’. 

3 (d) GROUNDS FOR REFUSING TO APPROVE AN AB4 BREVIATED NEW DRUG APPLICATION.—Section 505(j)(4) 

5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 355(j)(4)), is amended— 

7 (1) in subparagraph (J), by striking ‘‘or’’ at the 

8 end; 

9 (2) in subparagraph (K), by striking the period 

10 at the end and inserting ‘‘; or’’; and 

11 (3) by adding at the end the following: 

12 ‘‘(L) if the drug is a drug described in 

13 paragraph (2)(A)(ix) and the applicant has not 

14 proposed technologies, controls, or measures re15 lated to the packaging or disposal of such drug 

16 that the Secretary determines are comparably 

17 effective to those required for the applicable 

18 listed drug under section 505–2.’’. 

19 (e) RULES OF CONSTRUCTION.— 

20 (1) Any labeling describing technologies, con21 trols, or measures related to packaging, storage, or 

22 disposal intended to mitigate the risk of abuse or 

23 misuse of a drug product that is subject to an abbre24 viated new drug application, including labeling de25 scribing differences from the reference listed drug 


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1 resulting from the application of section 505–2 of 

2 the Federal Food, Drug, and Cosmetic Act, as 

3 added by subsection (a), shall not be construed— 

4 (A) as changes to labeling not permissible 

5 under clause (v) of section 505(j)(2)(A) of such 

6 Act (21 U.S.C. 355(j)(2)(A)), or a change in 

7 the conditions of use prescribed, recommended, 

8 or suggested in the labeling proposed for the 

9 new drug under clause (i) of such section; or 

10 (B) to prohibit approval of an abbreviated 

11 new drug application under subparagraph (B) 

12 or (G) of section 505(j)(4) of such Act (21 

13 U.S.C. 355(j)(4)). 

14 (2) For a covered application that is an applica15 tion submitted under subjection (j) of section 505 of 

16 the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 355), subparagraph (j)(2)(A) of such section 

18 505 shall not be construed to limit the type of data 

19 or information the Secretary of Health and Human 

20 Services may request or consider in connection with 

21 making any determination under section 505–2. 

22 (f) GAO REPORT.—Not later than 12 months after 

23 the date of enactment of this Act, the Comptroller General 

24 of the United States shall prepare and submit to the Con25 gress a report containing— 


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1 (1) a description of available evidence, if any, 

2 on the effectiveness of site-of-use, in-home controlled 

3 substance disposal products and packaging tech4 nologies; 

5 (2) identification of ways in which such disposal 

6 products intended for use by patients, consumers, 

7 and other end users that are not registrants under 

8 the Controlled Substances Act, are made available to 

9 the public and barriers to the use of such disposal 

10 products; 

11 (3) identification of ways in which packaging 

12 technologies are made available to the public and 

13 barriers to the use of such technologies; 

14 (4) a description of Federal oversight, if any, of 

15 site-of-use, in-home controlled substance disposal 

16 products, including— 

17 (A) identification of the Federal agencies 

18 that oversee such products; 

19 (B) identification of the methods of dis20 posal of controlled substances recommended by 

21 these agencies for site-of-use, in-home disposal; 

22 and 

23 (C) a description of the effectiveness of 

24 such recommendations at preventing the diver25 sion of legally prescribed controlled substances; 


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1 (5) a description of Federal oversight, if any, of 

2 controlled substance packaging technologies, includ3 ing— 

4 (A) identification of the Federal agencies 

5 that oversee such technologies; 

6 (B) identification of the technologies rec7 ommended by these agencies, including unit 

8 dose packaging, packaging that provides a set 

9 duration, or other packaging systems that may 

10 mitigate abuse or misuse; and 

11 (C) a description of the effectiveness of 

12 such recommendations at preventing the diver13 sion of legally prescribed controlled substances; 

14 and 

15 (6) recommendations on— 

16 (A) whether site-of-use, in-home controlled 

17 substance disposal products and packaging 

18 technologies require Federal oversight and, if 

19 so, which agencies should be responsible for 

20 such oversight and, as applicable, approval of 

21 such products or technologies; and 

22 (B) the potential role of the Federal Gov23 ernment in evaluating such products to ensure 

24 product efficacy. 

Æ 


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